A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy (SEER-2)
Overview
- Phase
- Phase 3
- Intervention
- RGN-259
- Conditions
- Neurotrophic Keratopathy
- Sponsor
- ReGenTree, LLC
- Enrollment
- 70
- Locations
- 36
- Primary Endpoint
- Percentage of subjects achieving complete healing of PED at Day 29
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)
Detailed Description
Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of partial or total impairment of trigeminal innervation. The resulting loss of corneal sensitivity (anesthesia) leads to a reduction in lacrimation and a decline in status, metabolism, and mitosis of corneal epithelial cells.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
0.1% RGN-259 Opthalmic Solution
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days
Intervention: RGN-259
Placebo Ophthalmic Solution (Vehicle for RGN-259 Ophthalmic Solution)
It is composed of the same excipients as RGN-259 but does not contain Tβ4
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of subjects achieving complete healing of PED at Day 29
Time Frame: Day 29
Percentage of subjects achieving complete healing of the Persistent Epithelial Defect (PED) at Day 29 determined by corneal fluorescein staining as measured by the Central Reading Center.
Secondary Outcomes
- Visual Acuity determined by ETDRS(Day 8, 15, 22, 29, 36, and 43)
- NK stage by Mackie classification(Day 8, 15, 22, 29, 36, and 43)
- Corneal sensitivity inside the lesion determined by Cochet Bonnet aesthesiometer (Unit: mm)(Day 8, 15, 22, 29, 36, and 43)
- Percentage of subjects achieving complete healing of PED at Day 29(Day 29)
- Percentage change from baseline of lesion size(Day 8, 15, 22, 29, 36, and 43)